A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy, Safety, and Tolerability of AMG 785 in Adults with a Fresh Unilateral Hip Fracture, Status Post Surgical Fixation - Study To Assess FRacTure Healing with SclerosTin Antibody - Hip (STARTT-Hip)
- Conditions
- Acceleration of fracture healingMedDRA version: 12.1Level: LLTClassification code 10016454Term: Femur fracture
- Registration Number
- EUCTR2009-015939-33-LV
- Lead Sponsor
- Amgen Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 330
- Adult women or men, age = 55 to = 95 years at randomization
- Fresh unilateral low energy intertrochanteric or femoral neck fracture as the primary injury, confirmed by X-ray and in the opinion of the treating surgeon amenable to repair by internal fixation
- Intertrochanteric fractures eligible for this study must have at least two displaced fragments
- Internal fixation of the fracture with devices approved by local regulatory agency, performed no later than 7 days after injury for intertrochanteric or undisplaced femoral neck fractures and no later than 2 days after injury for displaced femoral neck fractures
• Intertrochanteric fracture: sliding hip screw or IM nail
• Femoral neck fracture: sliding hip screw or at least three cancellous screws
- Pre- and postoperative care performed as defined in Appendix I
- Subject or subject’s legally acceptable representative has provided informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Conditions that may affect the ability to perform functional or clinical
assessments required by the protocol, such as:
• Severe symptomatic osteoarthritis of the lower extremity
• Inability to independently rise from armchair or walk 200 meters before hip fracture (use of unilateral assistive device or rolling walker is acceptable)
• Cognitive deficit, as defined by Mini-Mental Status Examination score < 22 at time of randomization
• Symptomatic neurological conditions such as Parkinson’s disease or persistent
gross motor or sensory deficits such as hemiparesis or hemiplegia
• Presence of concomitant injuries such as rib fractures, wrist fractures, or acute
symptomatic vertebral fractures which severely impair the ability to rise from a chair
• Associated extremity injuries including ipsilateral or contralateral fractures of the
foot, tibia or fibula, wrist, humerus, femoral shaft, femoral head or hip dislocation,
that may delay weight-bearing beyond one week after surgery
- Use of bone grafts or bone substitutes at the time of fracture fixation
- Head-injury, as defined by Glasgow Coma Scale <13 prior to randomization
- Major polytrauma or significant axial trauma, with Injury Severity Score > 16
- Pathological fracture or history of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as Paget’s disease, rheumatoid arthritis, osteomalacia, osteopetrosis, ankylosing spondylitis, Cushing’s disease, hyperprolactinemia
- History of symptomatic spinal stenosis that has not been surgically corrected. If surgically corrected, the subject must be asymptomatic to be eligible for the study
- History of facial nerve paralysis
- Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical carcinoma in situ) within the last 5 years
- Severe asthma or severe chronic obstructive pulmonary disease or recent exacerbation
- Myocardial infarction or unstable angina pectoris within the last 12 months
- Current alcohol dependence
- History of solid organ or bone marrow transplants
- Per subject report, chart review or local laboratory result, evidence of currently abnormal values for the following:
• Elevated transaminases (a) Serum aspartate aminotransferase = 2.0 x upper limits of normal; (b) Serum alanine aminotransferase = 2.0 x upper limits of normal
• Significantly impaired renal function as determined by a derived creatinine clearance of = 30 mL/min using the Modification of Diet in Renal Disease equation (Levey et al, 1999). The estimated glomerular filtration rate is calculated as follows: estimated glomerular filtration rate (mL/min/1.73m2)= 186 x [Serum creatinine (mg/dL)]-1.154 x [Age]-0.203 x [0.742 if subject is female] x [1.210 if subject is black].
• Hypocalcemia or hypercalcemia, outside of 1.1 x the normal range set by the local laboratory
- Known to have tested positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigen
- Use of the following agents affecting bone metabolism
• Within the past 12 months: parathyroid hormone, strontium, fluoride (for osteoporosis)
• Within the past 6 months: IV bisphosphonates, denosumab, odanacatib (MK-0822)
• Within the past 3 months: calcitonin, tibolone, cinacalcet, systemic glucocorticosteroids (= 5 mg prednisone equivalent per day for more than 10 days)
- Bone Morphogenetic Protein (BMP)-2 or BMP-7 at the time of definitive fracture fixation
- Subjects to be
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the effect of AMG 785 compared to placebo on functional healing as<br>measured by the timed-up-and-go test (TUG) over Weeks 6 through 20 in subjects with fresh unilateral low energy hip fractures.;Secondary Objective: To investigate the effect of AMG 785 compared to placebo on:<br>• TUG by visit<br>• Time to radiographic healing<br>• Harris Hip Score<br>• Pain as a result of the hip fracture as assessed by the Visual Analog Scale (VAS);Primary end point(s): The primary endpoint is the difference in mean TUG over Weeks 6 through Week 20 between the AMG 785 and placebo groups.<br>
- Secondary Outcome Measures
Name Time Method